Plain English Summary
Background and study aims
Heavy bleeding after childbirth, known as postpartum haemorrhage (PPH), is a major cause of maternal death in the developing world. PPH can be prevented using uterotonic drugs, which cause the uterus (womb) to contract. Misoprostol can be used to prevent PPH as it is affordable, has a long shelf-life, and can be taken by mouth (orally). Currently misoprostol is mostly used in healthcare facilities and self-administration at home is not promoted. The aim of this study is to assess the effectiveness and safety of misoprostol tablets taken immediately after home delivery for the prevention of PPH.
Who can participate?
Pregnant women (more than 34 weeks gestation) living in the participating villages of Mbale district of Eastern Uganda.
What does the study involve?
Participants are randomly allocated to be given either a trial pack of misoprostol or placebo (dummy) tablets to be self-administered orally after delivery. Participants are trained on how to take the pills following delivery and a picture guide will also be included with the pills.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Liverpool Women's Hospital (UK).
When is the study starting and how long is it expected to run for?
January 2012 to January 2015.
Who is funding the study?
Bill and Melinda Gates Foundation (USA).
Who is the main contact?
Prof. Andrew Weeks
aweeks@liv.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Andrew Weeks
ORCID ID
Contact details
International Maternal Health
Sanyu Research Unit
Department of Women's and Children's Health
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 706 4101
aweeks@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v5.6 10/07/2011
Study information
Scientific title
A pilot study of self-administered Misoprostol to prevent bleeding after childbirth in the community (MamaMiso)
Acronym
Study hypothesis
Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally.
We envisage that the use of self-administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot).
The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.
Ethics approval
1. Mbale Regional Hospital Institutional Research Committee (MRHIRC), 25/03/2011, ref: REIRC 010/2011
2. University of Liverpool (UK), 05/08/2011, ref: UoL000694
3. Uganda National Council for Science and Technology (UNCST), 07/10/2011, ref: HS 1059
Study design
Placebo-controlled randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the main contact details to request a patient information sheet
Condition
Postpartum hemorrhage (PPH)
Intervention
Once the pregnant women are seen in antenatal clinic and give informed consent to participate in the trial, they will be given either trial pack of misoprostol (600mcg) or identical placebo to be self-administered orally after delivery. She will be trained to take the pills following delivery using adapted teaching tools used successfully in Nepal and Afghanistan. A picture guide on how to take the medication will also be included with the mediation in the study neck purse.
Intervention type
Drug
Phase
Not Applicable
Drug names
Misoprostol
Primary outcome measures
Peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot) following use of self-administered misoprostol after home birth
Secondary outcome measures
1. The rate of poor maternal and fetal health at 3-5 days after delivery
2. Side effects, and safety (to include transfer to hospital, surgical intervention, blood transfusion and maternal death)
The exact outcomes as well as the power calculations will only be finalized once the pilot study is completed.
Overall trial start date
01/01/2012
Overall trial end date
01/01/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pregnant women living in the recruitment villages of Mbale district at more than 34 weeks gestation
2. High risk women will not be excluded from the pilot study, even if they state their intention to deliver in a health facility
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
The pilot will allow us determine the primary outcome and thereafter help us determine the number for the main study. The pilot will recruit as many as possible during this time.
Participant exclusion criteria
1. Any pregnant woman with a known allergy to misoprostol or other prostaglandins
2. Any woman under 18 years old (unless she is an emancipated minor)
Recruitment start date
01/01/2012
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Uganda
Trial participating centre
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
University of Liverpool (UK)
Sponsor details
Department of Women's and Children's Health
Liverpool Women's Hospital
Crown Street
Liverpool
L69 3BX
United Kingdom
+44 (0)151 706 4101
aweeks@liv.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Bill and Melinda Gates Foundation
Alternative name(s)
Bill & Melinda Gates Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26370443